Neurostimulation device

ABSTRACT

The present disclosure describes an implantable lead device that includes an internal support comb. The support comb can include one or more faces that enable the alignment, routing, and holding of the lead device&#39;s internal wires. The support comb can enable the interconnection of the wires with to the microelectrode film that includes the lead device&#39;s electrodes.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 120 as acontinuation of U.S. patent application Ser. No. 16/901,583, titled“NEUROSTIMULATION DEVICE,” filed Jun. 15, 2020, which claims priorityunder 35 U.S.C. § 120 as a continuation of U.S. patent application Ser.No. 15/910,278, titled “NEUROSTIMULATION DEVICE,” filed Mar. 2, 2018 andissued on Jul. 7, 2020 as U.S. Pat. No. 10,702,692, each of which isincorporated herein by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

Deep brain stimulation (DBS) can include neurostimulation therapy thatinvolves electrical stimulation systems that stimulate the human brainand body. DBS can be used to treat a number of neurological disorders.DBS can involve electrically stimulating a target area of the brain.

SUMMARY OF THE DISCLOSURE

The present disclosure describes a stimulation device that can be formedinto a cylindrical shape. Internally, the stimulation device can includea silicon etched support comb with faces to align, route, and holdwires. The support comb can enable the interconnection of the wires withthe microelectrode film that includes the stimulation device'selectrodes. The stimulation device can also include an internal supporttube that can reduce mechanical detachment of the microelectrode filmfrom its epoxy mold by providing a long edge anchoring system. Themicroelectrode film can be rolled into a three-dimensional configurationto increase the degrees of freedom during the assembly process.

According to at least one aspect of the disclosure an implantable leaddevice can include a support comb. The support comb can include anattachment face and a routing face. The routing face can include aplurality of slots. The lead device can include a microelectrode film.The microelectrode film can include a body. The body can include aplurality of electrodes. The microelectrode film can include anextension extending from the body. The extension can include a firstface. The first face of the extension can include a plurality ofelectrical contacts coupled with the plurality of electrodes. Theextension can include a second face. The second face of the extensioncan be coupled with the attachment face of the support comb. The leaddevice can include a plurality of wires. Each of the plurality of wirescan pass through a respective one of the plurality of slots and couplewith a respective one of the plurality of electrical contacts.

The attachment face can include a channel to route an adhesive under atleast a portion of the second face of the microelectrode film. A firstface of the body of the microelectrode film can be coupled with thesupport tube. The support tube can include a plurality of radio opaquemarkers that can be aligned with the plurality of electrodes. Thesupport tube can include a plurality of merlons on a first end. Thefirst end can be configured to mate with or receive the support comb.

The lead device can include a support tube that can include a pluralityof radio opaque markers. Each of the plurality of wires can be coupledwith a respective one of the plurality of electrical contacts via wirebonding.

The extension of the microelectrode film can include a first leg and asecond leg. The first leg can include the first face of the extensionand the second face of the extension. The second leg can include aplurality of traces coupling a subset of the plurality of electrodes tothe plurality of electrical contacts.

The first leg and the second leg of the extension can be rolled aroundthe support comb. The lead device can include an epoxy backfill of themicroelectrode film to form a probe shaft.

According to at least one aspect of the disclosure, a method tomanufacture an implantable lead device can include providing a supportcomb. The support comb can include an attachment face and a routingface. The routing face can include a plurality of slots. The method caninclude coupling a first portion of a microelectrode film with theattachment face of the support comb. The first portion of themicroelectrode film can include a plurality of electrical contacts. Themethod can include positioning each of a plurality of wires through arespective one of the plurality of slots of the routing face. The methodcan include coupling each of the plurality of wires with a respectiveone of the plurality of electrical contacts. The method can includerolling a second portion of the microelectrode film about the supportcomb.

The method can include forming a second portion of the microelectrodefilm. The second portion can include a plurality of electrodes inelectrical communication with the plurality of electrical contacts. Themethod can include forming a third portion of the microelectrode film.The third portion can include a plurality of electrical traces couplinga portion of the plurality of electrodes to a portion of the pluralityof electrical contacts.

The method can include coupling a second portion of the microelectrodefilm to an outer face of a support tube. The second portion of themicroelectrode film can include a plurality of electrodes. The methodcan include over molding the support comb with an epoxy.

The method can include forming a plurality of radio opaque markers in asupport tube. The method can include aligning the plurality of radioopaque markers with a plurality of electrodes formed in themicroelectrode film. The plurality of radio opaque markers can be offsetfrom the plurality of electrodes.

The method can include wire bonding each of the plurality of wires withthe respective one of the plurality of electrical contacts. The methodcan include rolling a second portion of the microelectrode film to forma cylinder. The method can include filling the cylinder with an epoxy.

The method can include under filling a channel formed in the attachmentface with an epoxy to couple the first portion of the microelectrodefilm with the attachment face. The method can include etching thesupport comb in silicon.

The method can include coupling a first edge of the microelectrode filmwith a second edge of the microelectrode film to form a cylinder. Themethod can include inserting the first and second edges of themicroelectrode film into a slit of a support tube.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. Likereference numbers and designations in the various drawings indicate likeelements. For purposes of clarity, not every component may be labeled inevery drawing. In the drawings:

FIG. 1 illustrates an example system to perform neurostimulation.

FIG. 2 illustrates the stimulation lead for use in the systemillustrated in FIG. 1 .

FIG. 3 illustrates a perspective view of the distal end of thestimulation lead illustrated in FIG. 2 .

FIG. 4 illustrates a top view of the microelectrode film for use in thestimulation lead illustrated in FIG. 2 .

FIG. 5 illustrates the microelectrode film in a rolled configuration.

FIG. 6 illustrates an example support tube for use in the stimulationlead illustrated in FIG. 2 .

FIG. 7 illustrates the microelectrode film coupled with the supporttube, as viewed from the distal end of the support tube.

FIGS. 8-10 illustrate an example support comb for use in the stimulationlead illustrated in FIG. 2 .

FIGS. 11-14 illustrate views of the distal end of the stimulation leadillustrated in FIG. 2 .

FIG. 15 illustrates a partial view of the interface between the supportcomb and the microelectrode film in the stimulation lead illustrated inFIG. 2 .

FIG. 16 illustrates a partial view of an example support comb that canbe used in the stimulation lead illustrated in FIG. 2 .

FIG. 17 illustrates a partial view of the coupling of the support combwith the support tube.

FIGS. 18 and 19 illustrate example configurations of the microelectrodefilm with tabs.

FIG. 20 illustrates an example support tube and markers for use in thesystem illustrated in FIG. 1 .

FIG. 21 illustrates an example support comb with a circularconfiguration for use in the system illustrated in FIG. 1 .

FIG. 22 illustrates an example method to manufacture the lead device foruse in the system illustrated in FIG. 1 .

DETAILED DESCRIPTION

The various concepts introduced above and discussed in greater detailbelow may be implemented in any of numerous ways, as the describedconcepts are not limited to any particular manner of implementation.Examples of specific implementations and applications are providedprimarily for illustrative purposes.

FIG. 1 illustrates an example system 50 for performing neurostimulation.The system 50 includes a stimulation lead 100 implanted into the brain54 of a patient 52. The stimulation lead 100 is coupled with astimulator 58 through cables 56. The stimulator 58 generatestherapeutic, electrical stimulations that can be delivered to thepatient's brain 54 by the stimulation lead 100. The stimulation lead 100can be an implantable lead device, which can be chronically or acutelyimplanted into the patient 52.

FIG. 2 illustrates the stimulation lead 100. The stimulation lead 100includes a distal end 110 and a proximal end 112. The distal end 110includes a plurality of electrodes 108. The proximal end 112 includes aplurality of terminal contacts 116. Each of the terminal contacts 116are electrically coupled with at least one of the electrodes 108. Forexample, a wire (or other electrical trace) can run through the interiorof the body 114 from one of the terminal contacts 116 to a contactdisposed toward the distal end 110 that is in electrical communicationwith the electrode 108.

FIG. 3 illustrates a perspective view of the distal end 110 of thestimulation lead 100. As an overview, the distal end 110 includes amicroelectrode film 104 with a plurality of electrodes 108. Themicroelectrode film 104 is coupled with a support tube 132. The distalend 110 also includes the support comb 102. The support comb 102 canenable the attachment of the wires 106 to the microelectrode film 104.The distal end 110 also includes a probe shaft 140. Components of thedistal end 110 are described below in connection to FIGS. 4-9 , amongothers, and the assembled distal end 110 is further described inconnection to FIGS. 10-17 , among others.

The distal end 110 includes a microelectrode film 104. FIG. 4illustrates a top view of the microelectrode film 104. FIG. 4illustrates the microelectrode film 104 in a planar configuration. Themicroelectrode film 104 includes a body 120 and an extension 122. Thebody 120 includes a plurality of electrodes 108. The extension 122includes a plurality of contacts 118. The contacts 118 can be coupledwith the electrodes 108 via traces 124.

The microelectrode film 104 includes the body 120. The body 120 caninclude a plurality of electrodes 108. The body 120 can include betweenabout 4 and about 64, between about 8 and about 32, between about 8 andabout 24, or between about 4 and about 12 electrodes 108. The electrodes108 can be configured as directional or omnidirectional electrodes. Forexample, in an omnidirectional configuration, the electrode 108 canextend substantially the height 126 of the body 120, such that theelectrode 108 wraps substantially around (e.g., at least 80%, or atleast 90%) the circumference of the distal end 110 when themicroelectrode film 104 is formed into a cylinder (as illustrated inFIG. 5 ). In a directional configuration, as illustrated in FIG. 4 , theelectrodes 108 only extend a portion of the height 126 of themicroelectrode film 104. For example, in a directional configuration theelectrodes 108 may each only extend between about 10% and about 80%,between about 10% and about 60%, between about 10% and about 40%, orbetween about 10% and about 25% of the height 126 of the body 120. Theelectrodes 108 can be grouped in column to span the height 126. One ormore of the directionally configured electrodes 108 can be electricallycoupled together to form an omnidirectional electrode 108. The couplingbetween at least two directionally configured electrodes 108 to form anomnidirectional electrode 108 can occur electrically by connecting twotraces 124 within microelectrode film 104 or by connecting terminalcontacts 116 via the wires 106.

The microelectrode film 104 can include a plurality of traces 124. Thetraces 124 can couple the electrodes 108 with one or more contacts 118.The microelectrode film 104 can include the same number of contacts 118and electrodes 108 such that each electrode 108 is coupled with a singlecontact 118. The microelectrode film 104 can include fewer contacts 118than electrodes 108, such that more than one electrode 108 is coupledwith the same contact 118 (to form, for example, an omnidirectionalelectrode). Each trace 124 can make one or more connections with anelectrode 108. For example, a trace 124 can branch into two or moreperiphery traces that couple with the electrode 108 at couple with theelectrode 108 at several points around the periphery of the electrode108. Making multiple connections with each of the electrodes 108 canincrease the reliability of the microelectrode film 104.

The extension 122 can include the contacts 118. The contacts 118 canprovide an interface where the wires 106 are coupled with themicroelectrode film 104. For example, each of the wire 106 can be wirebonded or laser bonded with a respective one of the contacts 118.

The extension 122 can include a first leg 128 and a second leg 130. Thecontacts 118 can be disposed on a first face of the first leg 128. Thefirst leg 128 can also include an opening 158 disposed toward each endof the first leg 128. The openings 158 can be holes through the firstleg 128. The openings 158 can align with inlets that are formed in theattachment face of the support comb 102 (and described further below inrelation to FIG. 8 , among others). The second leg 130 can include asubset of the traces 124 that run from the contacts 118 to theelectrodes 108. Running the subset of the traces 124 along the secondleg 130 can enable a greater number of traces 124 (and thereforeelectrodes 108) to be incorporated into the microelectrode film 104 whencompared to a system that routes the traces 124 along a single leg.

FIG. 5 illustrates the microelectrode film 104 in the rolledconfiguration. As illustrated, opposite edges of the body 120 are rolledtoward one another to form a cylinder. The second leg 130 is rolledabout the first leg 128 to form a second portion of the cylinder. Asdescribed in relation to FIGS. 5 and 6 , among others, the body 120 canbe rolled about a support tube.

FIG. 6 illustrates an example support tube 132. The support tube 132 caninclude a plurality of markers 134. The support tube 132 can include aslot 136. The proximal end of the support tube 132 can include aplurality of merlons 138.

The support tube 132 can include a radio opaque metal, such as a medicalgrade stainless steel, non-metal materials, such as plastic, or acombination thereof. The support tube 132 can include a plurality ofmarkers 134. The markers 134 can be radio opaque. For example, themarkers 134 can be visible when the stimulation lead 100 is imaged witha CT scanner or x-ray. When the support tube 132 is manufactured from aradio opaque metal, the markers 134 can be holes or voids in the body ofthe support tube 132. The markers 134 can pass through the wall of thesupport tube 132. When the markers 134 are holes through the wall of thesupport tube 132, the regions without the markers 134 can be relativelymore radio opaque when compared to the portions of the support tube 132with the markers 134. The electrodes 108 can be aligned with the markers134. The electrodes 108 can be aligned with the regions between themarkers 134. The support tube 132 can be manufactured in a plasticmaterial and the markers 134 can be made radio opaque by either, alocalized doping of the polymer such as Boron bombardment or bybackfilling with a doped polymer for example Boron doped plastic.

The support tube 132 can include a plurality of merlons 138. The merlons138 can be a plurality of extensions that extend from one end of thesupport tube 132. Each merlon 138 can be separated from a neighboringmerlon 138 by a gap or crenel. Each of the merlons 138 can be aboutbetween about 0.2 mm and about 2 mm, between about 0.4 mm and about 1.5mm, between about 0.2 mm and about 1 mm, or between about 0.4 mm andabout 0.6 mm long. The merlons 138 can have a circumferential pitch ofabout 0.1 mm to about 2 mm, between about 0.1 mm and about 1.5 mm,between about 0.1 mm and about 1 mm, between about 0.1 mm and about 0.5mm, or between about 0.2 mm and about 4 mm.

The merlons 138 are configured to mate with the support comb 102. Themerlons 138 are configured to mate with the probe shaft of thestimulation lead 100. The probe shaft can be formed by an epoxyover-molding process. The merlons 138 can provide groves and ridged tointo which the epoxy can flow and bond to form the probe shaft.

The support tube 132 can include a slot 136. The slot 136 can run thelength of the support tube 132. The slot 136 can pass through the wallof the support tube 132 or can form a channel in the outer face of thesupport tube 132.

FIG. 7 illustrates the microelectrode film 104 coupled with the supporttube 132, as viewed from the distal end of the support tube 132. A firstface of the body 120, which includes the electrodes 108 can facesoutward and away from the support tube 132. A second face of themicroelectrode film's body 120 is coupled with the external face of thesupport tube 132 to form a cylinder. The opposing edges of the body 120are inserted through the slot 136.

FIG. 8 illustrates an attachment face of the support comb 102 and afirst routing face 144 of the support comb 102. The attachment face 142includes a channel 148. The attachment face 142 of the support comb 102is configured to couple with a face of the microelectrode film 104. Thechannel 148 is configured to route an adhesive under a portion of faceof the microelectrode film 104 that is coupled with the attachment face142. The channel 148 can be between about 5 μm and about 40 μm, betweenabout 10 μm and about 30 μm, or between about 10 μm and about 20 μm.During the manufacturing of the stimulation lead 100, a face of themicroelectrode film 104 can be coupled with the attachment face 142 ofthe support comb 102 through a mechanical means, such as a clamp. Theinlets 150 can extend past the portion of the microelectrode film 104that is coupled with the attachment face 142. An adhesive can be addedto the inlets 150. Capillary action can transport the adhesive along thelength of the channel 148 and under the face of the microelectrode film104 that is coupled with the attachment face 142. Once the adhesivesets, the mechanical means for holding the microelectrode film 104against the attachment face 142 can be released.

The support comb 102 can include a first routing face 144. The firstrouting face 144 can include plurality of slots 152 (which can also bereferred to as channels 152). The first routing face 144 can include aslot 152 for each of the wires 106. During the manufacturing process,each of the contacts 118 can be substantially aligned with one of theslots 152 to facilitate coupling the wires 106 with contacts 118. Forexample, each of the wires 106 can pass through a respective slot 152 toalign with a different contact 118. The pitch of the slots 152 can matchthe pitch of the contacts 118.

FIG. 9 illustrates a second routing face 154 of the support comb 102.The second routing face 154 is opposite the attachment face 142. Thesecond routing face 154 can include a plurality of fingers 156. Thefingers 156 are raised protrusions that can form channels 157 in thesecond routing face 154. Each of the channels 157 can terminate in ahole 159 that passed to the slots 152 on the first routing face 144.

FIG. 10 illustrates the second routing face 154 with wires 106 passingalong the second routing face 154. The wires 106 can pass into thechannels 157 defined by the fingers 156. From the channels 157, thewires 106 can pass through the hole 159 at the end of the channel 157and into one of the respective slots 152 on the first routing face 144.The color coding of the wires 106 can enable the appropriate routing ofwires 106 from each one of the terminal contacts 116 to thecorresponding electrodes 108 of the distal end 110.

FIGS. 11-14 illustrate different face views of the distal end 110. Eachof the views illustrated in FIGS. 11-14 illustrate a view of the distalend 110 of the stimulation lead 100 rotated 90 degrees with respect tothe previous FIG. For example, FIG. 11 can be said to illustrate a topview of the distal end 110, FIG. 12 can be said to illustrate a firstside view of the distal end 110, FIG. 13 can be said to illustrate abottom view of the distal end 110, and FIG. 14 can be said to illustratea second side view of the distal end 110. The preceding “top”, “firstside,” “second side,” and “bottom” are provided for reference only asany face of the distal end 110 can serve as the “top,” “bottom,” etc.For example, the placement of the electrodes 108 around thecircumference of the distal end 110 enable any face (or angle) of thedistal end 110 to serve as the top, bottom, or side of the distal end110.

Referring to FIGS. 11-14 together, among others, the distal end 110includes the microelectrode film 104. The microelectrode film 104includes a plurality of electrodes 108. The electrodes 108 are coupledwith the terminal contacts 116 via the wires 106. The distal end 110also includes the support comb 102. The support comb 102 can facilitatethe management of the wires 106 within the shaft of the distal end 110.The support comb 102 can also secure or hold the terminating ends of thewires 106 near the contacts of the microelectrode film 104. Positing theterminating ends of the wires 106 near the contacts of themicroelectrode film 104 can enable for improved efficiencies inmanufacturing as the support comb 102 can provide alignment between thewires 106 and the contacts 118 of the microelectrode film 104.

FIG. 15 illustrates an enlarged view of the interface between thesupport comb 102 and the microelectrode film 104. FIG. 15 illustratesthe microelectrode film 104 in the rolled or cylindrical configuration.The extension 122 of the microelectrode film 104 is rolled around thesupport comb 102 such that support comb 102 is positioned within a lumendefined by the rolled (or cylindrical) microelectrode film 104. Thesecond leg 130 is wrapped around the support comb 102 and positionedtoward the support comb's second routing face 154 (illustrated in FIG.15 as the backside of the support comb 102). The first leg 128 can becoupled with the attachment face 142.

The first leg 128 of the microelectrode film 104 can be coupled with theattachment face 142. The first leg 128 can include a first face thatincludes the contacts 118 and a second face, opposite the first face,that can couple with the support comb 102. The second face can becoupled with the attachment face 142. The first leg 128 can bepositioned on the attachment face 142 such that the opening 158substantially aligns with the inlet 150. For example, before rolling theextension 122 around the support comb 102, an adhesive can be deliveredto the inlet 150 through the opening 158 in the first leg 128. Throughcapillary action, the adhesive can flow through the channel 148 andunder the first leg 128 to couples the first leg 128 (e.g., the secondface of the first leg 128) with the attachment face 142.

Coupling the first leg 128 with the attachment face 142, the contacts118 can be substantially aligned with the slots 152. The contacts 118can be offset from the slots 152. For example, each of the contacts 118can be positioned between neighboring slots 152. The slots 152 canenable wire management and position the wires 106 in a correct positionfor bonding with the contacts 118. For example, the wires 106 can passthrough each of the slots 152 to align with one of the contacts 118. Thewires 106 can be coupled with the contacts 118. The wires 106 can bewire bonded or welded with the contacts 118.

FIG. 16 illustrates an enlarged view of the support comb 102. FIG. 16substantially illustrates the back side of the support comb 102 (anddistal end 110) with respect to FIG. 15 .

As illustrated, the second leg 130 of the microelectrode film 104 isrolled around the support comb 102. The wires 106 pass along the secondrouting face 154 of the support comb 102. Each of the wires 106 passthrough a channel formed by the fingers 156. The wires 106 can passthrough a hole 159 formed at the end of the channel 157 and into theslots 152. The fingers 156 (and the channels formed thereby) can enablerouting of the wires 106 along the support comb 102 and to the slots 152where the wires 106 can be coupled with the contacts 118.

FIG. 17 illustrates an enlarged view of the coupling of the support comb102 with the support tube 132. A first end of the support comb 102 caninclude a knob or other structure that is configured to fit within aportion of the support tube 132. The merlons 138 can surround the knobat the first end of the support comb 102. The probe shaft 140 can beformed through an epoxy over molding process. The epoxy can flow intothe areas between the merlons 138 to form a probe shaft 140 that iscoupled with the support tube 132. The epoxy of the probe shaft 140 canencase the support comb 102 and the second leg 130 within the body ofstimulation lead's distal end 110. The probe shaft 140 can be formedfrom an injection molding or micromachining process.

FIGS. 18 and 19 illustrate an example configuration of themicroelectrode film 104 and method for forming the microelectrode film104 into a cylinder. FIG. 19 illustrates the body 120 portion of themicroelectrode film 104 in a partially rolled state. A first edge of thebody 120 can include a plurality of tabs 160. The opposite edge (ortowards the opposite edge) can include a plurality of slots 162. Thebody 120 can include a slot 162 for each of the tab 160. The tabs 160can be tapered—narrowing as the tab 160 extends from the body 120. Forexample, the tabs 160 can be shaped like the head of an arrow. Each ofthe tabs 160 can slide into a respective one of the slots 162. The tabs160 can include a barb that locks the tab 160 into the slot 162 once thetab 160 is inserted into the slot 162 past the barb. FIG. 19 illustratesthe body 120 with the tabs 160 fully inserted into the slots 162 to forma cylinder.

FIG. 20 illustrates an example support tube 132 and markers 134. Theexample support tube 132 illustrated in FIG. 20 can be manufactured froma non-magnetic or non-radio opaque material. The markers 134 can bemanufactured from a radio opaque material. The support tube 132 caninclude a plurality of grooves 164. The grooves 164 can be shaped toreceive the markers 134. The markers 134 can be secured into the grooves164 with an adhesive, clip, or pressure fitting. When the microelectrodefilm 104 is coupled with the support tube 132, the electrodes 108 can bealigned with the markers 134.

FIG. 21 illustrates an example support comb 102 in a circularconfiguration. The support comb 102 can include a plurality of slots 152around the circumference of the support comb 102. The extension of themicroelectrode film 104 can be disk shaped and can include a pluralityof contacts 118 distributed toward the circumference of the extension.The wires 106 can pass through each of the slots 152 toward the contacts118. The slots 152 can align the wires 106 with the contacts 118. Thewires 106 can be wire bonded or welded to the contacts 118.

FIG. 22 illustrates an example method 200 to manufacture a lead device.The method 200 can include providing a support comb (BLOCK 202). Themethod 200 can include positioning a plurality of wires (BLOCK 204). Themethod 200 can include coupling the support comb with a microelectrodefilm (BLOCK 206). The method 200 can include coupling the wires with themicroelectrode film (BLOCK 208). The method 200 can include rolling themicroelectrode film (BLOCK 210).

As set forth above, the method 200 can include providing a support comb(BLOCK 202). Referring also to FIGS. 1-21 , the support comb 102 caninclude an attachment face 142 and first routing face 144. The firstrouting face 144 can include a plurality of slots 152. Themicroelectrode film 104 can include a second routing face 154. Thesecond routing face 154 can include a plurality of fingers 156 that formchannels on the second routing face 154. The channels 157 can terminatein a hole 159 that connects the channels 157 of the second routing face154 with the slots 152 of the first routing face 144. The attachmentface 142 can include a channel 148.

The support comb 102 can be manufactured by an injection moldingprocess, a micro-machining process, a photolithography process, or3D-printing process. The support comb 102 can be manufactured fromsilicon, plastic, metal, liquid crystal polymers (LCP), or othermaterial. Radio opaque materials can include included into the supportcomb 102 to enable the distal end 110 to be visualized during an X-ray.For example, the polymers used in an injection molding process can bedoped with a radio opaque material such as Barium Sulfate (BaSO4),Boron, or metal rings, bands, or components can be incorporated into thesupport comb 102.

The method 200 can include positioning the wires (BLOCK 204). Referringto FIG. 10 , among others, the wires 106 can uncoil and run along thesecond routing face 154. The second routing face 154 can arrange thewires 106. The second routing face 154 can include a plurality offingers 156 that can define channels 157. A wire 106 can pass through arespective channel 157 and through a hole 159 at the end of the channel157 that couples the channel 157 with a slot 152. Each of the wires 106can pass through a respective one of the slots 152. The slots 152 canhold and position the wires 106. For example, the slots 152 can holdeach of the wires 106 in a fixed proximity to a respective contact 118.

The method 200 can include coupling the support comb 102 with amicroelectrode film 104 (BLOCK 206). The microelectrode film 104 caninclude different portions. For example, the microelectrode film 104 caninclude a body 120 and an extension 122. The body 120 can include aplurality of electrodes 108. The extension 122 can include a pluralityof legs. One of the legs can include a plurality of contacts 118. Boththe extension 122 and the body 120 can include a plurality of traces124.

The microelectrode film 104 can include a stack of insulating andconducting layers. The microelectrode film can be a thin-film,microelectromechanical systems (MEMS) electrode film. The conductinglayers can include the traces 124, the contacts 118, and the electrodes108. The different conducting layers can be isolated from one another bythe insulating layers. The insulating layers can also isolate theconducting layers (or portions thereof) from the external environment.The microelectrode film 104 can be manufactured as a planar film usingadditive manufacturing processes.

The microelectrode film 104 can be coupled with the support comb 102 bycoupling a first portion of the microelectrode film 104 with theattachment face 142. For example, a portion of the extension 122 can becoupled with the attachment face 142. The first leg 128 of the extension122, which can include a plurality of contacts 118 can be coupled withthe attachment face 142. The face opposite the face with the contacts118 can be coupled with the attachment face 142 such that the contacts118 faces away from the support comb 102.

When coupling the microelectrode film 104 with the support comb 102, theopenings 158 of the extension 122 can be aligned with the inlets 150 ofthe support comb 102. The microelectrode film 104 can be coupled withthe support comb 102 by applying an adhesive to the inlets 150.Capillary force can drive the adhesive from the inlets 150 and throughthe channel 148 to underfill the space between the microelectrode film104 and the support comb 102 formed by the channel 148. Once cured, theadhesive can couple the microelectrode film 104 with the support comb102.

The method 200 can include coupling the wires with the microelectrodefilm (BLOCK 208). Also, Referring to FIG. 15 , among others, the wires106 can pass through a respective channel on the second routing face 154and into a respective slot 152. The slot 152 can position each of thewires 106 near one of the contacts 118. The wires 106 can be coupledwith the contacts 118 with wire bonding, welding, or laser bonding.

The method 200 can include rolling the microelectrode film (BLOCK 210).The extension 122 of the microelectrode film 104 can be rolled about thesupport comb 102. The body 120 of the microelectrode film 104 can berolled about the support comb 102. Rolling the extension 122 about thesupport comb 102 can place the second leg 130 of the extension 122 nearthe second routing face 154 of the support comb 102.

The body 120 of the microelectrode film 104 can be rolled about thesupport tube 132. The microelectrode film 104 can be coupled with theouter face of the support tube 132. The support tube 132 can include aslot 136. Opposite edges of the body 120 can be inserted into the slot136.

Once the microelectrode film 104 is rolled, the microelectrode film 104and support comb 102 can be placed in a mold. The mold can be filledwith an epoxy. The epoxy over molding can form a probe shaft 140. Theprobe shaft 140 can encase the extension 122, the support comb 102, andat least a portion of the wires 106. The probe shaft 140 can flow intothe merlons 138 and couples with the support tube 132.

While operations are depicted in the drawings in a particular order,such operations are not required to be performed in the particular ordershown or in sequential order, and all illustrated operations are notrequired to be performed. Actions described herein can be performed in adifferent order.

The separation of various system components does not require separationin all implementations, and the described program components can beincluded in a single hardware or software product.

Having now described some illustrative implementations, it is apparentthat the foregoing is illustrative and not limiting, having beenpresented by way of example. In particular, although many of theexamples presented herein involve specific combinations of method actsor system elements, those acts and those elements may be combined inother ways to accomplish the same objectives. Acts, elements andfeatures discussed in connection with one implementation are notintended to be excluded from a similar role in other implementations orimplementations.

The phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including” “comprising” “having” “containing” “involving”“characterized by” “characterized in that” and variations thereofherein, is meant to encompass the items listed thereafter, equivalentsthereof, and additional items, as well as alternate implementationsconsisting of the items listed thereafter exclusively. In oneimplementation, the systems and methods described herein consist of one,each combination of more than one, or all of the described elements,acts, or components.

As used herein, the term “about” and “substantially” will be understoodby persons of ordinary skill in the art and will vary to some extentdepending upon the context in which it is used. If there are uses of theterm which are not clear to persons of ordinary skill in the art giventhe context in which it is used, “about” will mean up to plus or minus10% of the particular term.

Any references to implementations or elements or acts of the systems andmethods herein referred to in the singular may also embraceimplementations including a plurality of these elements, and anyreferences in plural to any implementation or element or act herein mayalso embrace implementations including only a single element. Referencesin the singular or plural form are not intended to limit the presentlydisclosed systems or methods, their components, acts, or elements tosingle or plural configurations. References to any act or element beingbased on any information, act or element may include implementationswhere the act or element is based at least in part on any information,act, or element.

Any implementation disclosed herein may be combined with any otherimplementation or embodiment, and references to “an implementation,”“some implementations,” “one implementation” or the like are notnecessarily mutually exclusive and are intended to indicate that aparticular feature, structure, or characteristic described in connectionwith the implementation may be included in at least one implementationor embodiment. Such terms as used herein are not necessarily allreferring to the same implementation. Any implementation may be combinedwith any other implementation, inclusively or exclusively, in any mannerconsistent with the aspects and implementations disclosed herein.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

References to “or” may be construed as inclusive so that any termsdescribed using “or” may indicate any of a single, more than one, andall of the described terms. For example, a reference to “at least one of‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and‘B’. Such references used in conjunction with “comprising” or other openterminology can include additional items.

Where technical features in the drawings, detailed description or anyclaim are followed by reference signs, the reference signs have beenincluded to increase the intelligibility of the drawings, detaileddescription, and claims. Accordingly, neither the reference signs northeir absence have any limiting effect on the scope of any claimelements.

The systems and methods described herein may be embodied in otherspecific forms without departing from the characteristics thereof. Theforegoing implementations are illustrative rather than limiting of thedescribed systems and methods. Scope of the systems and methodsdescribed herein is thus indicated by the appended claims, rather thanthe foregoing description, and changes that come within the meaning andrange of equivalency of the claims are embraced therein.

What is claimed is:
 1. A stimulation lead device, comprising: amicroelectrode film, the microelectrode film including an extension; asupport comb, the support comb including: an attachment face to couplewith the extension of the microelectrode film; a slot to receive a wire;and a first finger and a second finger that define a channel, thechannel to receive the wire.
 2. The stimulation lead device of claim 1,comprising: the attachment face including a channel, wherein adhesivedisposed in the channel couples the support comb with the microelectrodefilm.
 3. The stimulation lead device of claim 1, comprising: a supporttube coupled with the microelectrode film, the support tube including atleast one of a marker and a merlon.
 4. The stimulation lead device ofclaim 1, wherein the extension of the microelectrode film comprises: afirst leg, the first leg having an electrical contact coupled with anelectrode; and a second leg, the second leg coupled with the attachmentface of the support comb.
 5. The stimulation lead device of claim 1,wherein the microelectrode film comprises: a first leg and a second leg,the first leg and the second leg rolled around at least a portion of thesupport comb.
 6. The stimulation lead device of claim 1, comprising: thesupport comb disposed at least partially within a volume defined by theextension of the microelectrode film.
 7. The stimulation lead device ofclaim 1, comprising: the support comb at least partially coupled withthe extension of the microelectrode film.
 8. The stimulation lead deviceof claim 1, comprising: the support comb including a routing face, therouting face including the slot to receive the wire.
 9. The stimulationlead device of claim 1, wherein the slot aligns the wire with a contact.10. The stimulation lead device of claim 1, comprising: the support combincluding a routing face, the routing face including the first fingerand the second finger, wherein the second finger is longer than thefirst finger.
 11. The stimulation lead device of claim 1, comprising:the support comb including an inlet, the inlet including an adhesive tocouple the support comb with the microelectrode film.
 12. Thestimulation lead device of claim 1, comprising: a probe shaft thatencases at least a portion of the extension of the microelectrode film,the probe shaft including epoxy.
 13. The stimulation lead device ofclaim 1, comprising: the microelectrode film and the support combdisposed at a distal end of the stimulation lead device.
 14. Thestimulation lead device of claim 1, wherein the extension of themicroelectrode film comprises: a trace to couple an electrode with acontact.
 15. The stimulation lead device of claim 1, wherein themicroelectrode film comprises: a body having an tab and a slot, the tabof the microelectrode film configured to engage with the slot of themicroelectrode film.
 16. The stimulation lead device of claim 1, whereinthe microelectrode film comprises: a body having a plurality ofelectrodes; a plurality of tabs along a first edge of the body; aplurality of slots along a second edge of the body, each of theplurality of slots of the microelectrode film to hold a correspondingtab of the plurality of tabs to define a volume at least partiallythrough the body of the microelectrode film.
 17. The stimulation leaddevice of claim 1, comprising: the extension of the microelectrode filmcoupled with the support comb, the extension including a plurality ofcontacts and a plurality of traces, each of the plurality of contactscoupled with one or more of a plurality of electrodes via at least oneof the plurality of traces.
 18. A method, comprising: providing asupport comb of an implantable device, the support comb including: anattachment face to couple with an extension of a microelectrode film; arouting face having a slot; and a first finger and a second finger thatdefine a channel, the channel to receive a wire; coupling a first leg ofa microelectrode film of the implantable device with the attachment faceof the support comb; positioning the wire through the slot of therouting face; coupling the wire with the microelectrode film; andforming a second leg of the microelectrode film about the support comb.19. The method of claim 18, wherein the attachment face includes achannel, comprising: disposing adhesive in the channel to couple thesupport comb with the microelectrode film.
 20. A method, comprising:providing a stimulation lead, the stimulation lead including: amicroelectrode film, the microelectrode film including an extension; asupport comb, the support comb including: an attachment face to couplewith the extension of the microelectrode film; a slot to receive a wire;and a first finger and a second finger that define a channel, thechannel to receive the wire.